SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD) announced today that it will launch its next-generation PediGuard “Threaded” device enabled by DSG™ (Dynamic Surgical Guidance) technology at next week’s 31st annual meeting of the North American Spine Society (NASS) in Boston on October 26-29.

The innovative PediGuard Threaded device with DSG is a drilling instrument with a threaded shaft design available in various sizes. It may be used to streamline surgical steps while maintaining the accuracy of pedicle preparation for screw placement. Additionally, it may reduce the use of intraoperative imaging in standard and MIS procedures.

“The PediGuard Threaded device is a transformative product in spine surgery. It combines the need to make a pilot hole and do a tap into one-step. As it is threaded, surgeons can get a very nice controlled advancement of the tip down through the pedicle, which gives steady feedback regarding the positioning of the pedicle screw pilot hole,” said Ciaran Bolger, MD, PhD, Professor of Clinical Neuroscience, Beaumont Hospital, Dublin, Ireland.

“Because we can be confident in our guided placement, we have been able to reduce the amount of fluoroscopy used during minimally invasive procedures. I estimate that, at our spine center, we have reduced the number of fluoroscopy images by about 50%,” said Larry T. Khoo, MD, The Spine Clinic of Los Angeles, California. “My practice is 90-100% minimally invasive, so I routinely use the PediGuard Threaded device in the vast majority of my cases. I use it in everything from routine lumbar to thoracic screw cannulations.”

"I have used the PediGuard Threaded device for CBT (cortical bone trajectory),” added Richard A. Hynes, MD, FACS, President of The B.A.C.K. Center in Melbourne, Florida. “Due to the significant cortical bone in this pedicle screw method, tapping of the bone is recommended. With the PediGuard Threaded device, I am able to benefit from a prospective warning of breaching the bone while performing the tapping step simultaneously. This may result in improved safety, efficiency and accuracy while consistently facilitating the longest possible screw lengths."

Stéphane Bette, CTO and Co-Founder of SpineGuard, concluded, “Learning now on 50,000 surgeries secured with DSG™ technology, SpineGuard continues to enhance the value offered to surgeons and hospitals with the US launch of our new, finely designed PediGuard Threaded range, further demonstrating how our DSG technology can be integrated within pedicle screw instrumentation for additional clinical benefits and efficiencies.”

SpineGuard reports 50,000 spine procedures performed using its family of PediGuard devices for accurate pedicle screw placement. The PediGuard product line includes the PediGuard Straight, PediGuard Curved, PediGuard Cannulated, and now, PediGuard Threaded.

The DSG™ screw was presented in a symposium on October 5 at the EUROSPINE Annual meeting in Berlin, Germany. The US-FDA clearance is progressing well with the company submission of the 510k on October 14.

SpineGuard will participate at Actionaria retail investor show on November 18 and 19 in Paris.

About SpineGuard®

Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. 50,000 surgical procedures have been performed worldwide with PediGuard. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. In 2015, SpineGuard started to expand the applications of DSG into pedicle screws through partnerships with innovative surgical companies in France and the US. SpineGuard has offices in San Francisco and Paris.

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

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